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Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01450306
First received: October 6, 2011
Last updated: March 25, 2016
Last verified: March 2016
Results First Received: May 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Specific Phobia
Interventions: Drug: D-cycloserine
Behavioral: Exposure therapy
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
D-cycloserine Plus Exposure Therapy Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
Placebo Plus Exposure Therapy Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session

Participant Flow:   Overall Study
    D-cycloserine Plus Exposure Therapy     Placebo Plus Exposure Therapy  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
D-cycloserine Plus Exposure Therapy Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
Placebo Plus Exposure Therapy Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Total Total of all reporting groups

Baseline Measures
    D-cycloserine Plus Exposure Therapy     Placebo Plus Exposure Therapy     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  39  (13.91)     34.6  (12.69)     37  (13)  
Gender  
[units: participants]
     
Female     6     6     12  
Male     4     4     8  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures
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1.  Primary:   Snake Questionnaire (SNAQ)   [ Time Frame: 2 weeks ]

2.  Secondary:   Clinician's Global Impression (CGI)-Severity   [ Time Frame: 2 weeks ]

3.  Secondary:   Clinician's Global Impression (CGI)-Improvement   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr David Tolin
Organization: Hartford Hospital
phone: 860-545-7685
e-mail: dtolin@harthosp.org


Publications of Results:

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01450306     History of Changes
Other Study ID Numbers: NAVE003220HU
Study First Received: October 6, 2011
Results First Received: May 24, 2012
Last Updated: March 25, 2016
Health Authority: United States: Institutional Review Board